US production of cell-based flu vaccines approved for the first time

For the first time, Food and Drug Administration has officially authorized a facility in North Carolina to begin producing a new, antibiotic-free influenza vaccine within the United States.

The announcement was made by Swiss pharmaceutical company
Novartis, which will be operating the plant in Holly Springs,
North Carolina. As noted in a press release, the operation will
be the first of its kind in the US. Now that it’s been cleared by
the FDA, the facility will be able to move forward with plans to
manufacture seasonal cell-culture influenza vaccines.

Additionally, the plant will also have the capability of quickly
ramping up vaccine production in the event of a pandemic.

"Cell-culture technology is the first major advancement in
influenza vaccine production in the US in more than 40 years. We
are proud to be at the forefront of this innovation, which will
allow us to deliver on our public health and health security
commitments," said Andrin Oswald of Novartis Vaccines in a
press release.

"With this award-winning, state-of-the-art facility, we will
be able to not only offer US consumers an antibiotic- and
preservative-free alternative for the yearly seasonal flu
vaccination, but also be better prepared for future pandemic
threats."

Since the production of cell-based vaccines is also more flexible
than the typical flu shot, the Novartis facility should also be
able to quickly adapt in case of a pandemic. The facility can
reportedly develop 150 million doses of a vaccine within six
months of a pandemic.

Specifically, the North Carolina-based plant will be
manufacturing the cell-based Flucelvax vaccine, which contains
zero antibiotics and zero preservatives. Although cell-culture
technology has been used to create other vaccines in the past –
polio and rubella shots, for example – Flucelvas was the first
kind approved by the FDA to combat the flu

According to the University of Minnesota’s Center for Infectious
Disease Research and Policy, Flucelvas made its US debut during
the 2013-2014 flu season, but was manufactured in Germany due to
lack of FDA approval. The vaccine has been in development since
2006, and the construction of the Holly Springs plant is the
result of collaboration between the Department of Health and
Human Services, which invested almost $500 million, and Novartis.